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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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BUN Reagent Kit - 00386100001988

Blood Urea Nitrogen Reagent Kit for use with EasyRA Analyzers
MEDICA CORPORATION
10202-4
In Commercial Distribution

  • 00386100001988 ()
10202-4

  • Urea IVD, kit, enzyme spectrophotometry

OsteoMed - 00845694047470

2.0mm, L Plates 23mm Rigid, Left & Right, with Screws, Sterile
OSTEOMED LLC
210-3008-SP
In Commercial Distribution

  • 00845694047470 ()
210-3008-SP

  • Craniofacial fixation plate kit, non-bioabsorbable

OsteoMed - 00845694044820

2.0mm, L Plates 18mm Rigid, Left & Right, with Screws, Sterile
OSTEOMED LLC
210-3007-SP
In Commercial Distribution

  • 00845694044820 ()
210-3007-SP

  • Craniofacial fixation plate kit, non-bioabsorbable

OsteoMed - 00845694044813

2.0mm, L Plates 15mm Rigid, Left & Right, with Screws, Sterile
OSTEOMED LLC
210-3006-SP
In Commercial Distribution

  • 00845694044813 ()
210-3006-SP

  • Craniofacial fixation plate kit, non-bioabsorbable

OXYGEN MASK CHILD, WITH 7FT TUBE(SMOOTH BORE),SINGLE PACKING - 04716770811246

OXYGEN MASK CHILD, WITH 7FT TUBE(SMOOTH BORE),SINGLE PACKING
BESMED HEALTH BUSINESS CORP.
OM-81124
In Commercial Distribution

  • 04716770811246 ()


  • Respiratory oxygen therapy system

OXYGEN MASK ADULT, WITH 7FT TUBE(SMOOTH BORE),SINGLE PACKING - 04716770811147

OXYGEN MASK ADULT, WITH 7FT TUBE(SMOOTH BORE),SINGLE PACKING
BESMED HEALTH BUSINESS CORP.
OM-81114
In Commercial Distribution

  • 04716770811147 ()


  • Respiratory oxygen therapy system

Paseo Knee - 00850013242306

MONOCENTRIC BRAKE KNEE JOINT WITH STANCE FLEXION AND MANUAL LOCK
CYPRESS ADAPTIVE, LLC
CA602-ML
In Commercial Distribution

  • 00850013242306 ()
CA602-ML

  • Single-axis stabilizing knee prosthesis

Power Dental USA - D943781820

BONE TACK TITANIUM 5mm BLUE WITH REMOVAL THREAD 5EA/PKG
Power Dental U.S.A. Inc.
7818-2
In Commercial Distribution

  • D943781820 ()
7818-2

  • Dressing/utility forceps, scissors-like, reusable
  • Intraoperative orthopaedic bone pin/screw, single-use

Power Dental USA - D94378181

BONE TACK TITANIUM 3mm RED WITH REMOVAL THREAD 5EA/PKG
Power Dental U.S.A. Inc.
7818-1
In Commercial Distribution

  • D94378181 ()
7818-1

  • Dressing/utility forceps, scissors-like, reusable
  • Intraoperative orthopaedic bone pin/screw, single-use

BritePro Omni - 05055931100461

BritePro Omni Single-Use Laryngoscope Mini Handle With Miller Ultra 1
FLEXICARE MEDICAL LIMITED
040-06-2010U
In Commercial Distribution

  • 05055931100461 ()


  • Rigid intubation laryngoscope, single-use
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